DOSE AND DOSE INTENSITY OF ADJUVANT CHEMOTHERAPY FOR STAGE-II, NODE-POSITIVE BREAST-CARCINOMA
DOSE AND DOSE INTENSITY OF ADJUVANT CHEMOTHERAPY FOR STAGE-II, NODE-POSITIVE BREAST-CARCINOMA
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DOI：
10.1056/nejm199405053301801
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发表时间：
1994-05-05
影响因子：
158.5
通讯作者：
HENDERSON, IC
中科院分区：
文献类型：
--
作者：
WOOD, WC;BUDMAN, DR;HENDERSON, IC
背景辅助化疗被广泛用于乳腺癌，并且已知可以延长生存期。一些临床医生通过增加剂量的强度来寻求更大的生存益处，而另一些临床医生则降低剂量以减少毒性。癌症和白血病组B（CALGB）在1572例淋巴结阳性II期乳腺癌女性患者中进行了一项不同剂量水平和剂量强度（每单位时间的剂量）辅助化疗的随机试验，这些患者被分配到3个治疗组。一组接受每平方米体表面积400 mg环磷酰胺和每平方米40 mg阿霉素，每28天一次，每平方米400 mg氟尿嘧啶，每28天两次，共6个周期。另一组接受的三种药物剂量高出50%（分别为600 mg，60 mg和600 mg），但仅持续4个周期，因此这两组的总剂量相同，但第二组的剂量强度更高。第三组妇女接受的总剂量为其他两组的一半，剂量强度为第二组的一半。在平均3.4年的随访后，接受高或中等剂量强度治疗的妇女的无病生存期明显延长（P
Background. Adjuvant chemotherapy is widely used for breast cancer and is known to extend survival. Some clinicians seek a greater survival benefit by increasing the intensity of the dose, whereas others lower it to diminish toxicity.Methods. The Cancer and Leukemia Group B (CALGB) conducted a randomized trial of different levels of doses and dose intensity (dose per unit of time) of adjuvant chemotherapy in 1572 women with node-positive, stage II breast cancer who were assigned to three treatment groups. One group received 400 mg of cyclophosphamide per square meter of body-surface area and 40 mg of doxorubicin per square meter once every 28 days and 400 mg of fluorouracil per square meter twice every 28 days, for six cycles. Another group received 50 percent higher doses of the three drugs (600 mg, 60 mg, and 600 mg, respectively) but for only four cycles, so that the total dose was identical in these two groups but the dose intensity was higher in the second. The third group of women received half the total dose used in the other two groups and at half the dose intensity used in the second group.Results. After a median of 3.4 years of follow-up, the women treated with a high or moderate dose intensity had significantly longer disease-free survival (P